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Methods for Estimating the Probability of Clonality in Cell Line Development
Author(s) -
Chen Chun,
Le Kim,
Le Huong,
Daris Kristi,
Soice Neil,
Stevens Jennitte,
Goudar Chetan T.
Publication year - 2020
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.201900289
Subject(s) - workflow , cloning (programming) , biopharmaceutical , computer science , computational biology , clone (java method) , biochemical engineering , biology , genetics , engineering , gene , database , programming language
Mammalian cell banks for biopharmaceutical production are usually derived from a single progenitor cell. Different methods to estimate the probability that the cell banks are clonally derived, or the probability of clonality (PoC), associated with various cloning workflows have been reported previously. In this review, a systematic analysis and comparison of the methods used to calculate the PoC are provided. As the single cell deposition and high‐resolution imaging technologies continue to advance and the cloning workflow evolves, an aligned understanding and best practice on estimating the PoC is necessary to compare different cloning workflows adopted across the biopharmaceutical industry and it will help to accelerate regulatory acceptance.